HIGH

Medline Recalls Pediatric Catheter Kits Over Seal Issues

Medline Industries, LP recalled 450 pediatric catheter securement kits on December 24, 2025. The kits may contain BD ChloraPrep Triple Swabsticks with potential open seals. Users should stop using the products immediately and follow recall instructions.

Quick Facts at a Glance

Recall Date
December 24, 2025
Hazard Level
HIGH
Brand
Medline Industries, LP
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

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Product Details

The recall involves Medline convenience kits packaged as Pediatric Catheter Securement Dressing, Kit SKU DYNDC3108. The affected items include UDI/DI 10193489918007 and Lot Number 25EBD612. The kits were distributed nationwide.

The Hazard

The recall was issued due to potential open seals on the packaging of the BD ChloraPrep Triple Swabsticks. This defect could compromise the sterility of the applicators, posing a risk of infection.

Reported Incidents

No specific incidents or injuries related to this recall have been reported. However, the potential for compromised sterility raises significant health concerns.

What to Do

Stop using the recalled kits immediately. Contact Medline Industries, LP or your healthcare provider for further instructions and follow the recall guidelines.

Contact Information

For more information, contact Medline Industries, LP. Visit the FDA website for further details: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1328-2026.

Key Facts

  • Recall Date: December 24, 2025
  • Report Date: February 18, 2026
  • Quantity Recalled: 450 kits
  • Hazard Level: High

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeMedical Convenience Kits
Sold At
Multiple Retailers

Product Details

Model Numbers
UDI/DI 10193489918007
Lot Number 25EBD612
Affected States
ALL
Report Date
February 18, 2026
Recall Status
ACTIVE

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